Research

RAF Current Clinical Trials

Below you will find information about current ongoing Clinical Trials at Retina Associates. Just click on any of the buttons below to open the specific research information.

DRY AMD - Geographic Atrophy

DIABETIC MACULAR EDEMA

DIABETIC RETINOPATHY ± MACULAR EDEMA:

RETINAL VEIN OCCLUSION

We encourage you to refer potential patients for free screening as they would benefit from participation in these studies. The trials are sponsored, so eligible patients will NOT incur additional costs and transportation is provided if needed.

If you have a patient with one of these conditions, please call us to make their referral appointment and mention the clinical trial when making the appointment. Please complete our Clinical Trial Referral Form and ask your patient to bring with them to their appointment.

If you are working on a weekend or after 5:00pm, please complete the Clinical Trial Referral Form and fill it out, then FAX it to our office. We will then contact the patient to make the appointment.

For the initial evaluation, the patient will need to provide their own transportation. If they qualify for the trial, then future transportation will be provided by RAF (via Uber or Taxi).

Questions:
Heidi Appenzeller
Study Coordinator
retinahv@tampabay.rr.com
813-875-6373 ext 239

Apellis Pharmaceuticals

COMPARES: APL-2 inj Q1 or Q2 mos to sham inj Q1 or Q2 mos
ELIGIBILITY: patients with areas of geographic atrophy, VA 20/320 or better
DURATION: pt is enrolled for 2 years
QUESTION: Will APL-2 prevent progression of GA

Government Clinical Trials page

Alkeus Pharmaceuticals

COMPARES: ALK-001 (modified, deuterated vitamin A) oral capsule taken once daily vs placebo
ELIGIBILITY: patients with areas of geographic atrophy, VA 20/320 or better
DURATION: pt is enrolled for 2 years
QUESTION: Will ALK-001 prevent progression of GA?

Government Clinical Trials Page

Genentech/Roche Pharmaceuticals

COMPARES: Ranibizumab Port Delivery System (RPDS) Q 6mo refill vs Lucentis Q1 mo injections
ELIGIBILITY: VA 20/400 or better. Diagnosed with WET AMD, less than 6 months treatment
DURATION: pt is enrolled for 2 years
QUESTION: is RPDS with q6 month refills more effective than Lucentis monthly

Government Clinical Trials page

Genentech/Roche Pharmaceuticals

COMPARES: faricimab (new drug) Q12-16 wks vs Eylea q8wk
ELIGIBILITY: VA 20/400 or better. Newly-diagnosed WET AMD with no prior treatment
DURATION: pt is enrolled for 2 years
QUESTION: Is faricimab Q16 wks more effective than Eylea Q8 wks

Government Clinical Trials page

Kodiak Pharmaceuticals


COMPARES: Kodiak KSI-301 Q16-20 weeks vs Aflibecerpt Q 8 weeks
ELIGIBILITY: Newly-diagnosed wet AMD with VA 20/25 or worse.
DURATION: Patients are enrolled for 2 years
QUESTION: Is Kodiak KSI-301 Q16-20 weeks noninferior to Aflibercept Q8 weeks?


Government Clinical Trials Page Link

Genentech/Roche Pharmaceuticals – Enrollment Completed

COMPARES: faricimab (new drug) q12-16 wk vs Eylea q8wk in pts with Diabetic Macular Edema
ELIGIBILITY: Type 1 or 2, VA: 20/40-20/400, no DME treatment in the last 3 months
DURATION: pt is enrolled for 2 years
QUESTION: Is faricimab dosed Q16 wk more effective than Eylea dosed q8wk

Government Clinical Trials Page

COMPARES: Ranibizumab Port Delivery System (RPDS) Q 6mo refill vs Lucentis Q1 mo injections
ELIGIBILITY: Type 1 or 2, VA: 20/40-20/400, no DME treatment in the last 3 months
DURATION: pt is enrolled for 2 years QUESTION: is RPDS with q6 month refills non-inferior to Lucentis monthly injections?

Government Clinical Trials Page

COMPARES: KSI-301 Q8-24 week injections vs Aflibercept Q8-week injections
ELIGIBILITY: Type 1 or 2, VA: 20/40-20/400, with DME (treatment naïve)
DURATION: pt is enrolled for 2 years
QUESTION: is KSI-301 Q8-24 weeks injections non-inferior to Aflibercept Q8 weeks injections?

Government Clinical Trials Page

COMPARES: Iluvien (fluocinolone 0.19 mg intravitreal implant) followed by as needed Aflibercept injections vs Aflibercept loading dose ( 5 injections given Q4 weeks) followed by as needed Aflibercept injections
ELIGIBILITY: Type 1 or 2, VA: 20/40-20/400, no DME treatment in the last 12 months
DURATION: pt is enrolled for 2 years
QUESTION: Will Iluvien group need less supplementary injections of Aflibercept than the Aflibercept loading group?

Government Clinical Trials Page

Genentech/Roche Pharmaceuticals

COMPARES: Ranibizumab Port Delivery System (RPDS) Q6 mo refill vs Lucentis Q1 mo injections
ELIGIBILITY: Type 1 or 2, VA: 20/40 or better, moderate to severe diabetic retinopathy with no previous treatment
DURATION: pt is enrolled for 2 years
QUESTION: is RPDS with q6 month refills non-inferior to Lucentis monthly injections?

Government Clinical Trials page 

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COMPARES: KSI-301 3 monthly injections followed by every 24 weeks injections vs Sham injections
ELIGIBILITY: Type 1 or 2 Diabetes Mellitus, VA: 20/40 or better, Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) with no DME (treatment naïve)
DURATION: pt is enrolled for 2 years
QUESTION: Does KSI-301 injections improve ETDRS Diabetic Retinopathy Severity Scale compared to sham injections? Does 
KSI-301 injections reduce the proportion of eyes developing sight threatening complications of diabetic retinopathy e.g. proliferative diabetic retinopathy, diabetic macular edema, anterior segment neovascularization compared to sham injections?
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COMPARES: KSI-301 Q8-week injections vs Aflibercept Q4-week injections
ELIGIBILITY: Branch- or Central-Retinal Vein Occlusion with center-involving macular edema (treatment naïve)
DURATION: pt is enrolled for 2 years QUESTION: Is KSI-301 q-8 week injections noninferior to Aflibercept q4-week injections?

Government Clinical Trials Page

COMPARES: Faricimab Q4-16-week injections vs Aflibercept Q4 week injections
ELIGIBILITY: Branch Retinal Vein Occlusion with Macular Edema (treatment naïve).
DURATION: pt is enrolled for 2 years
QUESTION: Will Faricimab Q4-16-week injection group be noninferior to the Aflibercept q4-week group

 

COMPARES: Faricimab Q4-16-week injections vs Aflibercept Q4 week injections
ELIGIBILITY: Central Retinal Vein Occlusion with Macular Edema (treatment naïve).
DURATION: pt is enrolled for 2 years
QUESTION: Will Faricimab Q4-16-week injection group be noninferior to the Aflibercept q4-week group